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In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus (SMWS03)

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ClinicalTrials.gov Identifier: NCT01369693
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : June 9, 2011
Sponsor:
Collaborator:
Swedish Match AB
Information provided by:
Contract Research Organization el AB

Brief Summary:
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smokeless Tobacco Harm Reduction Procedure: Buccal administration of nicotine Phase 1

Detailed Description:

Comparisons:

A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.

D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.

Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
Study Start Date : May 2004
Primary Completion Date : August 2004
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Cadmium
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: General Portion 1 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • PREP
Active Comparator: Catch Licorice Portion 1 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • PREP
Active Comparator: Catch Licorice Portion Mini 0.5 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • PREP
Active Comparator: Catch Licorice Portion Dry Mini 0.3 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • PREP



Primary Outcome Measures :
  1. In-vivo extraction of cadmium [ Time Frame: 30 minutes' use ]
    Extracted amount = mean of 10 unused sachets - residual amount


Secondary Outcome Measures :
  1. in-vivo extraction of tobacco specific nitrosamines (TSNAs)
    Extracted amount = mean of 10 unused sachets - residual amount in used sachet

  2. In-vivo extraction of lead [ Time Frame: 30 minutes' use ]
    Extracted amount = mean of 10 unused sachets - residual amount in one used sachet

  3. In-vivo extraction of nicotine [ Time Frame: 30 minutes' use ]
    Extracted amount = mean of 10 unused sachets - residual amount in one used sachet



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non-smokers, 18 to 50 years of age.
  • Habitual use of > 7 portions snus daily since minimum 1 year.
  • Healthy according to the health declaration and interview.
  • Written informed consent given.

Exclusion Criteria:

  • Concurrent participation in another clinical trial.
  • History of allergy.
  • History of allergy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369693


Locations
Sweden
CROel AB
Helsingborg, Sweden, SE25284
Sponsors and Collaborators
Contract Research Organization el AB
Swedish Match AB
Investigators
Principal Investigator: Erik Lunell, MD, PhD Croel AB

Responsible Party: Erik Lunell, MD, PhD, CROel AB
ClinicalTrials.gov Identifier: NCT01369693     History of Changes
Other Study ID Numbers: 2004/3
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by Contract Research Organization el AB:
smokeless tobacco
Nicotine
Cadmium
lead
Tobacco Specific Nitrosamines

Additional relevant MeSH terms:
Nicotine
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents